Drug Delivery System

ABSTRACT

Apparatuses and methods for coating and/or loading a medical device with a therapeutic agent prior to or during the placement of the medical device within the patient&#39;s body. In one variation, the medical device is coated and/or loaded with a therapeutic agent while the device is positioned in a delivery apparatus. In another variation, the delivery apparatus comprises a reservoir for retaining a therapeutic agent. The user may release the therapeutic agent from the reservoir prior to or during the placement of the device to coat and/or load the device with the therapeutic agent.

PRIORITY

This application is a division of U.S. patent application Ser. No.11/994,294, now U.S. Pat. No. 8,206,348, which is a U.S. National StageApplication under 35 U.S.C. §371 of International Patent Application No.PCT/US2006/026786, filed Jul. 7, 2006, which claims the benefit under 35U.S.C. §119(e) to U.S. Provisional Patent Application No. 60/697,649,filed Jul. 8, 2005, each of which is incorporated by reference into thisapplication as if fully set forth herein.

BACKGROUND OF THE INVENTION

The introduction of drug-eluting stents (DES) has been a majoradvancement in the field of cardiovascular medicine due to the abilityof the stents, which are coated with a drug, to prevent restenosis of avessel. Previous bare metal stents were only able to reduce the rate ofrestenosis, caused by intimal hyperplasia, to approximately 20-25%. Themedicine or drug that is associated with the DES is delivered directlyto the blockage site, reducing restenosis rates even further. However,implantable medical devices that are pre-coated with drugs may have asignificantly shorter shelf-life than their non-coated counterparts. Forexample, the potency of the drug may decrease over time, such that theexpiration date of the device must take into account the degradation ofdrug. In addition, viability concerns may prevent one from manufacturinga stent pre-coated with drugs and substances that degenerate within ashort period of time at room temperature. For example, drugs, which arebased on large molecule biologics (e.g., DNA, protein, monoclonalantibodies, etc.) may be particularly susceptible to degradation, andtherefore are difficult to implement as a pre-coated layer on a stent.Furthermore, because most pre-coated devices do not permit the medicalpractitioner to change or modify the drug associated with the device,the pre-coated devices may limit the medical practitioner's ability todetermine and implement the best medication/device combination based onspecific treatment needs.

Examples of current drug delivery devices and methods are disclosed inU.S. Patent Application, Publication No. 2004/0010309 A1, titled“METHODS AND SYSTEMS FOR DELIVERING LIQUID SUBSTANCES TO TISSUESSURROUNDING BODY LUMENS” by Seward et al., published Jan. 15, 2004; U.S.Pat. No. 6,699,282 B1 titled “METHOD AND APPARATUS FOR DELIVERY OFMEDICATION” issued to Sceusa, dated Mar. 2, 2004; U.S. Pat. No.6,656,162 B2 titled “IMPLANTABLE DRUG DELIVERY STENTS” issued toSantini, Jr. et al., dated Dec. 2, 2003; U.S. Pat. No. 6,613,084 B2titled “STENT HAVING COVER WITH DRUG DELIVERY CAPABILITY” issued toYang, dated Sep. 2, 2003; U.S. Pat. No. 6,344,028 B1 titled“REPLENISHABLE STENT AND DELIVERY SYSTEM” issued to Barry, dated Feb. 5,2002; U.S. Pat. No. 5,954,693 titled “REPLENISHABLE STENT AND DELIVERYSYSTEM” issued to Barry, dated Sep. 21, 1999; U.S. Pat. No. 5,857,998titled “STENT AND THERAPEUTIC DELIVERY SYSTEM” issued to Barry, datedJan. 12, 1999; U.S. Pat. No. 5,755,722 titled “STENT PLACEMENT DEVICEWITH MEDICATION DISPENSER AND METHOD” issued to Barry et al., dated May26, 1998; U.S. Pat. No. 5,685,847 titled “STENT AND THERAPEUTIC SYSTEM”issued to Barry, dated Nov. 11, 1997; and U.S. Pat. No. 5,439,446 titled“STENT AND THERAPEUTIC SYSTEM” issued to Barry, dated Aug. 8, 1995; eachof which is incorporated herein by reference in its entirety.

SUMMARY OF THE INVENTION

Disclosed herein are various apparatuses and methods for loading and/orcoating a medical device (e.g., stents, stent grafts, endovasculargrafts, vascular filters, etc.) with a therapeutic agent (e.g., drugs,pharmaceuticals, antithrombogenic agents, anti-inflammatory agents,antibacterial agents, anti-viral agents, biologics, DNAs, RNAs, viralvectors, monoclonal antibodies, growth factors, cells, stem cells,cartilage scaffolds, etc.) immediately prior to or during the placementof the medical device within a patient's body. In one variation, thedelivery apparatus is configured such that a medical device, loaded inthe delivery apparatus, can be coated or infused with a therapeuticagent while the medical device is positioned in the delivery apparatus.In another variation, the delivery apparatus is configured such that amedical device housed in the delivery apparatus is coated or infusedwith a therapeutic agent as the medical device is being ejected out ofthe delivery apparatus and into the patient's body. In yet anothervariation, the delivery apparatus is configured to simultaneouslydeliver a medical device and a therapeutic agent into a treatment areawithin the patient's body.

For example, the delivery apparatus may include a reservoir for holdinga drug. The user can release the drug from the reservoir to coat amedical device loaded in the delivery apparatus prior to or during theinsertion of the delivery apparatus into the patient's body. In anotherexample, a capsule containing a therapeutic agent is positioned in thedistal portion of the delivery apparatus. The user can break the capsuleand release the therapeutic agent to infuse or cover the medical devicesecured in the delivery apparatus whenever he or she is ready to do so.The capsule may be pressurized to facilitate the distribution of thetherapeutic agent in the distal portion of the delivery apparatus.

In another example, the delivery apparatus includes a chamber at thedistal portion of the apparatus for housing the medical device. Asuction mechanism is provided in the delivery apparatus to draw atherapeutic agent, in the form of liquid or gel, into the chamber tocoat and/or load the medical device. In one variation, the suctionmechanism is positioned within the body of the apparatus. A negativepressure is generated by the suction mechanism, which results in thetherapeutic agent positioned at the distal opening of the deliveryapparatus entering the apparatus due to the surrounding atmosphericpressure. In one particular design, the delivery apparatus includes acatheter and a slidable insert forming a seal against the catheter lumenwall. As the insert is displaced proximally relative to the catheter,suction is generated in the lumen of the catheter, and the therapeuticagent positioned at the distal opening of the catheter is drawn into thecatheter lumen. As the therapeutic agent fills the distal portion of thecatheter lumen, the medical device disposed therein is coated and/orloaded with the therapeutic agent. In another variation, a suctionmechanism is coupled to the proximal end of the delivery apparatus. Amedical device is disposed in a distally positioned chamber in thedelivery apparatus. The distal chamber housing the medical device is influid communication with the suction mechanism. This fluid communicationmay be established through a channel extending from the proximal end ofthe delivery apparatus to the distal end of the delivery apparatus. Thesuction mechanism generates a negative pressure in the channel to drawthe therapeutic agent positioned at the distal end of the deliveryapparatus into the distal chamber. As the therapeutic agent enters thedistal chamber, the medical device disposed therein is coated and/orloaded with the therapeutic agent.

In another example, the delivery apparatus includes a drug deliverylumen which provides a fluid conduit for infusing a therapeutic agentinto a chamber in the distal portion of the apparatus. A medical devicehoused in the chamber can be coated with a therapeutic agent at theuser's discretion. A pressurized foam or mist may be injected into thedelivery lumen to coat the medical device prior to or during theimplantation process.

In another variation, the delivery apparatus includes a reservoir at thedistal end thereof, through which a medical device can be delivered. Theuser may fill the reservoir with a therapeutic agent, such that when themedical device is delivered therethrough, the medical device is coatedwith the therapeutic agent. In another design variation, the deliveryapparatus includes two lumens in fluid communication with a chamber,which houses a medical device at the distal portion of the deliveryapparatus. A therapeutic agent can be injected into the first lumen andextracted through the second lumen, such that a continuous flow oftherapeutic agent is delivered over the medical device to coat and/orload the medical device with the therapeutic agent prior toimplantation.

In yet another variation, the medical device is coated or infused with atherapeutic agent under pressure, while positioned inside the body ofthe delivery apparatus, after which the medical device is deployed intothe patient's body. For example, an aerospray-can carrying a therapeuticagent can be coupled to the distal end of the delivery apparatus toinject therein the therapeutic agent. The injected therapeutic agent isdeposited onto and/or absorbed into the medical device. In anotherexample, the medical practitioner couples a syringe filled with atherapeutic agent onto the distal end of the delivery apparatus, andthen injects the therapeutic agent into the lumen of the deliveryapparatus by depressing the plunger on the syringe. The tip of thesyringe may be configured for insertion into the distal end of thedelivery apparatus. In another variation, a universal syringe adaptormay be provided to couple syringe of various sizes to the deliveryapparatus. In yet another example, a pressurized drug capsule isattached to the distal end of the delivery apparatus. The user canrelease the drug from the capsule and infuse the drug into the lumen ofthe delivery apparatus, which houses the medical device.

Methods for loading, coating or infusing a medical device with atherapeutic agent, while the medical device is disposed in the deliveryapparatus, are also disclosed herein. In one approach, the therapeuticagent and the medical device are stored separately. For example, atherapeutic agent comprising biologics, which requires low temperaturestorage, is placed in a refrigerator, while the delivery apparatus alongwith a medical device is stored in a cabinet. The medical device may bepre-loaded into the delivery apparatus and provided to the hospital orclinic as an integrated unit. When the medical practitioner is ready toimplant the medical device, the therapeutic agent can be infused intothe delivery apparatus to coat and/or load the medical device. Themedical practitioner may also personally check and ensure that a freshand active therapeutic agent is loaded into the delivery apparatus.Furthermore, the medical practitioner may be provided with two or moretherapeutic substances, from which he or she can elect for loading ontothe medical device. In another variation of the method, the therapeuticagent is released onto the intended treatment site as the medical deviceis being deployed by the delivery apparatus.

These and other embodiments, features and advantages of the presentinvention will become more apparent to those skilled in the art whentaken with reference to the following more detailed description of theinvention in conjunction with the accompanying drawings that are firstbriefly described.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates one variation of a delivery apparatus comprising achamber for housing a medical device for delivery and a reservoir forholding a therapeutic agent. In this particular design, a capsule isutilized to contain the therapeutic agent.

FIG. 2 illustrates another variation of a delivery apparatus including acapsule for containing a therapeutic agent.

FIG. 3 illustrates one variation of a capsule, which can be removablyinserted into a delivery apparatus.

FIG. 4 illustrates another variation of a delivery apparatus including abuilt-in stopper to allow the user to extract a liquid/gel carrying atherapeutic agent into a distal chamber, which houses a medical devicefor deployment.

FIG. 5 illustrates another variation of a delivery apparatus configuredwith a chamber for housing an implantable medical device for deployment.The chamber is also configured for receiving a therapeutic agent tocoat/load the medical device.

FIG. 6 illustrates another variation of a delivery apparatus with avalve positioned within the lumen of a catheter to form a chamber at thedistal portion of the catheter. In this variation, the position of thevalve can be displaced within the lumen of the catheter.

FIG. 7 illustrates another variation of a delivery apparatus including areservoir at the distal end thereof, through which a medical device canbe delivered.

FIG. 8 illustrates another variation of a delivery apparatus including achamber in which a medical device can be coated/loaded with atherapeutic agent prior to delivery into a patient's body.

FIG. 9 illustrates another variation of a delivery apparatus including astopper and a valve to form a chamber for coating/loading the medicaldevice with a therapeutic agent prior to deployment of the medicaldevice.

FIG. 10 illustrates another variation of a delivery apparatus with areservoir located with a slidable element. The reservoir can be utilizedto hold a therapeutic agent. The slidable element may also serve as apusher for deploying an implantable medical device placed in the distallumen of the delivery apparatus.

FIG. 11A illustrates another variation of a delivery apparatus withbuilt-in a displacement control mechanism to control the pusher rod. Acapsule is positioned within the distal end of the pusher rod to serveas a reservoir for a therapeutic agent.

FIG. 11B illustrates an activation element for use with the deliveryapparatus of FIG. 11A. The activation element, when inserted into theproximal end of the pusher rod, allows the user to break the capsule andrelease the therapeutic agent.

FIG. 12 illustrates another variation of a delivery apparatus includinga valve positioned within a catheter to form a chamber at the distal endof the catheter. In this variation, the position of the valve is fixedwithin the lumen of the catheter.

FIG. 13 illustrates another variation of a delivery apparatus comprisinga dual lumen catheter. A first lumen provides a channel to allow theuser to control the deployment of a medical device positioned within achamber at the distal end of the apparatus. A second lumen provides afluid conduit to allow the user to infuse a therapeutic agent into thedistal chamber.

FIG. 14 illustrates another variation of a delivery apparatus with adual lumen design. In this example, the apparatus is configured withcoaxial lumens and a pusher element slidably positioned within thecentral lumen.

FIG. 15 illustrates another variation of a delivery apparatus with acoaxial lumen design. An insert is slidably positioned within the outerlumen to serve as a suction mechanism to draw a therapeutic agent intothe distal portion of the apparatus.

FIG. 16 illustrates another variation of a delivery apparatus where apusher element for deploying the medical device is configured with alumen. The lumen may be utilized for infusing the distal portion of theapparatus with a therapeutic agent.

FIG. 17 illustrates another variation of a delivery apparatus comprisinga delivery catheter with a tubing slidably disposed therein. The tubingserves as a mechanism to deploy a medical device. The lumen within theinner slidable tubing serves as a fluid conduit for deliveringtherapeutic agent to coat/load the medical device while the medicaldevice is positioned within the distal end of the apparatus.

FIG. 18 illustrates another variation of a delivery apparatus comprisinga slidable element positioned within the lumen of a catheter fordeploying the medical device. The slidable element is configured with asuction mechanism which can be utilized to draw fluids into the distalend of the apparatus.

FIG. 19A illustrates another variation of a delivery apparatus includinga pusher pad configured with flanges. The radially extending flanges mayassist with engagement of a stent placed within the lumen of thedelivery catheter.

FIG. 19B is a frontal view of the delivery apparatus of FIG. 19A, shownwithout the stent.

FIG. 20 illustrates another variation of a delivery apparatus includinga slidable insert configured to distribute a therapeutic agent over amedical device placed within the lumen of the delivery apparatus.

FIG. 21A illustrates another variation of a delivery apparatuscomprising a delivery catheter with a first lumen for housing a medicaldevice and a second lumen configured to distribute a therapeutic agentover the medical device. As shown in the example of FIG. 21A, the outerlumen is configured with inner facing orifices to inject the therapeuticagent over the outer circumferential surface of the medical device.

FIG. 21B is a cross-sectional view of the delivery apparatus of FIG.21A. The cross-section is taken at A-A as shown in FIG. 21A.

FIG. 22 illustrates another dual lumen delivery apparatus configured fordeploying a vascular filter. In this particular design, the deliveryapparatus is configured with a mechanism (i.e., pusher element) forejecting the medical device (i.e., vascular filter).

FIG. 23 illustrates yet another dual lumen delivery apparatus design. Inthis example, a stent is placed over a compressed balloon on a ballooncatheter. An optional cap may be provided to allow the user totemporarily seal the distal end of the apparatus while the user coats orloads the stent with a therapeutic agent infused through the elongatedlumens of the apparatus.

FIG. 24 illustrates another dual lumen delivery apparatus configuredwith a pusher element. The pusher element is configured with a lumen forfluid delivery.

FIG. 25 illustrates a method for coating and/or infusing an implantablemedical device under pressure, while the device is loaded within adelivery apparatus.

FIG. 26 illustrates another variation of a delivery apparatus comprisinga reservoir of therapeutic agent that can be attached to the distal endof the delivery catheter to coat/infuse the medical device positionedwithin the delivery catheter. In this particular example, the reservoirincludes a pressurized capsule loaded with a therapeutic agent. When theintegrity of the capsule is included, the therapeutic agent is releasedinto the lumen of the delivery catheter.

FIG. 27 illustrates yet another variation of a delivery apparatusincluding a breakaway reservoir attached to the distal end of a deliverycatheter. Once the therapeutic agent within the breakaway reservoir hasbeen released into the lumen of the delivery catheter, the user candetach the breakaway reservoir.

FIG. 28 illustrates another variation of a delivery apparatus comprisinga delivery catheter with orifices on the circumferential surface, suchthat pressurized therapeutic agent can be infused into the lumen of thedelivery catheter through these orifices. In the example shown in FIG.28, an optional adaptor is provided to assist the user in injecting atherapeutic agent through circumferentially positioned orifices.

FIG. 29 illustrates another example for infusing the distal portion of adelivery catheter with a therapeutic agent. In this example, an adaptoris attached to the distal end of the delivery catheter, such that apressurized therapeutic agent is infused into the delivery catheterthrough the circumferential orifices to coat the medical device withinthe lumen of the delivery catheter. The excess therapeutic agent isallowed to exit the distal end of the delivery catheter through anoutlet on the adaptor.

FIG. 30 illustrates yet another variation of a delivery apparatuscomprising a sponge-like reservoir within the distal lumen of theapparatus. The sponge-like reservoir can be pre-loaded with atherapeutic agent, such that when the medical device is deployed throughthe distal end of the catheter, the sponge-like reservoir will coat orwick the circumferential surface of the device with the therapeuticagent. The example shown in FIG. 30 is configured to deploy a stent witha balloon catheter.

FIG. 31 illustrates another example of utilizing a delivery apparatuswith a sponge-like reservoir. In this example, the apparatus isconfigured with a pusher element for deploying a stent.

The following detailed description should be read with reference to thedrawings, in which identical reference numbers refer to like elementsthroughout the different figures. The drawings, which are notnecessarily to scale, depict selective embodiments and are not intendedto limit the scope of the invention. The detailed descriptionillustrates by way of example, not by way of limitation, the principlesof the invention. This description would enable one skilled in the artto make and use the invention, and describes several embodiments,adaptations, variations, alternatives and uses of the invention,including what is presently believed to be the best mode of carrying outthe invention.

Before describing preferred embodiments, it is to be understood thatunless otherwise indicated, this invention need not be limited toapplications in humans. As one skilled in the art would appreciate,variations of the invention may be applied to other mammals as well.Moreover, it should be understood that embodiments of the presentinvention may be applied in combination with various catheters, tubingintroducers or other implantation and connection devices for placementof a medical device into a patient's body.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Vascular filters, stents and endovascular stent-grafts are used hereinas examples of the types of medical devices to be implanted with adelivery apparatus that possesses the integrated capability to deliver atherapeutic agent onto the medical device, in order to illustrate thevarious aspects of the invention disclosed herein. In light of thedisclosure herein, one skilled in the art would appreciate thatvariations of the delivery apparatus may be utilized for placement ofdifferent medical devices, not specifically discussed herein, into apatients' body. Certain variations of the delivery apparatus describedin the preferred embodiments of the present invention are particularlyuseful for pre-loading a medical device with a therapeutic agent priorto insertion of the medical device into the patient's body. Othervariations of the delivery apparatus according to the present inventioncan be configured for simultaneous delivery of a therapeutic agentduring the deployment of the medical device. In addition, somevariations may support both pre-loading and simultaneous delivery oftherapeutic agents.

It must also be noted that, as used in this specification and theappended claims, the singular forms “a,” “an” and “the” include pluralreferents unless the context clearly dictates otherwise. Thus, forexample, the term “a chamber” is intended to mean a single chamber or acombination of chambers, “a fluid” is intended to mean one or morefluids, or a mixture thereof. Furthermore, the words “proximal” and“distal” refer to directions closer to and away from, respectively, amedical practitioner operating the apparatus, with the tip end (i.e.,distal end) placed inside the patient's body. Thus, for example, acatheter end placed within the body of the patient would be the distalend of the catheter, while the catheter end outside the patient's bodywould be the proximal end of the catheter.

In one preferred embodiment, the delivery apparatus is configured with areservoir for containing a therapeutic agent. The therapeutic agent canbe released while the medical device is still secure within the deliveryapparatus and/or during the placement of the medical device within thepatient's body. In one variation, the delivery apparatus includes achamber for housing the medical device, a reservoir for containing thetherapeutic agent, and a mechanism for deploying a medical device fromthe body of the delivery apparatus. The delivery apparatus may furtherinclude the medical device disposed in the chamber of the deliveryapparatus.

The drug or therapeutic agent can be one or more bio-active agents. Thebio-active agents can include, but are not limited to, vasodilator,anti-coagulants, such as, for example, warfarin and heparin. Otherbio-active agents can include, but are not limited to, agents such as,for example, anti-proliferative/antimitotic agents including naturalproducts such as vinca alkaloids (i.e. vinblastine, vincristine, andvinorelbine), paclitaxel, epidipodophyllotoxins (i.e. etoposide,teniposide), antibiotics (dactinomycin (actinomycin D) daunorubicin,doxorubicin and idarubicin), anthracyclines, mitoxantrone, bleomycins,plicamycin (mithramycin) and mitomycin, enzymes (L-asparaginase whichsystemically metabolizes L-asparagine and deprives cells which do nothave the capacity to synthesize their own asparagine); antiplateletagents such as G(GP) II_(b)/III_(a) inhibitors and vitronectin receptorantagonists; anti-proliferative/antimitotic alkylating agents such asnitrogen mustards (mechlorethamine, cyclophosphamide and analogs,melphalan, chlorambucil), ethylenimines and methylmelamines(hexamethylmelamine and thiotepa), alkyl sulfonates-busulfan,nirtosoureas (carmustine (BCNU) and analogs, streptozocin),trazenes-dacarbazinine (DTIC); anti-proliferative/antimitoticantimetabolites such as folic acid analogs (methotrexate), pyrimidineanalogs (fluorouracil, floxuridine, and cytarabine), purine analogs andrelated inhibitors (mercaptopurine, thioguanine, pentostatin and2-chlorodeoxyadenosine {cladribine}); platinum coordination complexes(cisplatin, carboplatin), procarbazine, hydroxyurea, mitotane,aminoglutethimide; hormones (i.e. estrogen); anti-coagulants (heparin,synthetic heparin salts and other inhibitors of thrombin); fibrinolyticagents (such as tissue plasminogen activator, streptokinase andurokinase), aspirin, dipyridamole, ticlopidine, clopidogrel, abciximab;antimigratory; antisecretory (breveldin); anti-inflammatory: such asadrenocortical steroids (cortisol, cortisone, fludrocortisone,prednisone, prednisolone, 6α-methylprednisolone, triamcinolone,betamethasone, and dexamethasone), non-steroidal agents (salicylic acidderivatives i.e. aspirin; para-aminophenol derivatives i.e.acetominophen; indole and indene acetic acids (indomethacin, sulindac,and etodalac), heteroaryl acetic acids (tolmetin, diclofenac, andketorolac), arylpropionic acids (ibuprofen and derivatives), anthranilicacids (mefenamic acid, and meclofenamic acid), enolic acids (piroxicam,tenoxicam, phenylbutazone, and oxyphenthatrazone), nabumetone, goldcompounds (auranofin, aurothioglucose, gold sodium thiomalate);immunosuppressives: (cyclosporine, tacrolimus (FK-506), sirolimus(rapamycin), azathioprine, mycophenolate mofetil); angiogenic agents:vascular endothelial growth factor (VEGF), fibroblast growth factor(FGF); angiotensin receptor blockers; nitric oxide donors; anti-senseoligionucleotides and combinations thereof; cell cycle inhibitors, mTORinhibitors, and growth factor receptor signal transduction kinaseinhibitors; retenoids; cyclin/CDK inhibitors; HMG co-enzyme reductaseinhibitors (statins); and protease inhibitors.

FIG. 1 illustrates the example where a delivery apparatus 2 includes areservoir 4 containing a therapeutic agent. In this particular design,the delivery apparatus 2 includes an elongated catheter 6 and a capsule8 positioned in the distal portion of the catheter lumen 10. The capsule8 serves as a reservoir for holding a therapeutic agent. Optional ledges12, 14 are provided on the catheter lumen wall to prevent the capsule 8from displacing in the proximal direction. In one variation, the capsule8 includes a polymeric material. A pusher element 16 is slidablypositioned within the lumen of the catheter. The pusher element 16includes a flexible rod extending through a central lumen of the capsule8 and a pusher pad 20 attached to the distal end of the flexible rod 18.The pusher pad 20 is configured with a plurality of channels 22, suchthat fluids may flow from the proximal side of the pusher pad towardsthe distal side of the pusher pad. Raised profiles 24 are provided onthe proximal side of the pusher pad for engaging the capsule 8 andreleasing the therapeutic agent from the capsule. In one variation, theraised profiles 24 include a plurality of sharp edges that can cut intothe distal end of the capsule 8 to break open the capsule and releasethe therapeutic agent contained therein. A medical device 30, such as avascular filter, ca be positioned in the lumen at the distal end 32 ofthe catheter 6.

To release the therapeutic agent from the capsule 8, the pusher element16 is displaced in the proximal direction to break the capsule 8. Oncethe capsule is broken, the therapeutic agent flows out of the capsuleand infuses the distal portion of the catheter lumen. In one variation,the compartment within the capsule is pressurized to facilitate thedispersion of the therapeutic agent when the integrity of the capsule iscompromised. The therapeutic agent flows over the vessel filter andcoats the vessel filter with a layer of therapeutic agent. In onevariation, the therapeutic agent includes a gel, and in anothervariation, the therapeutic agent includes a liquid.

As discussed herein, various other medical devices, such as for examplestents, grafts, stent-grafts, etc., can be placed in the lumen of thiscatheter for delivery into a patient's body. In one variation, themedical device includes an absorbing component for retaining a portionof the therapeutic agent that flows over the medical device. After themedical device has been implanted, the absorbing component will releasethe therapeutic agent to the implantation site over a period of time.For example, a porous polymer layer may be incorporated on the medicaldevice to retain the therapeutic agent. Once the medical device 30 isloaded and/or coated with the therapeutic agent, the user can advancethe pusher element 16 to eject the medical device out of the distal end32 of the catheter 6. In one approach, the user can release the capsuleand coat and/or load the medical device prior to inserting the catheterinto the patient's body. Once the catheter is inserted into thepatient's body, the pusher wire can be advanced distally to deploy themedical device. In another approach, the catheter is inserted into thepatient's body first. Once the catheter is positioned in the desiredlocation, the capsule with the therapeutic agent is released, followedby the deployment of the medical device. In another variation, a lockingmechanism is provided at the proximal end of the delivery apparatus tolock the deploying mechanism (e.g., pusher element) in position whilethe apparatus is being transported, in order to prevent accidentalrelease of the therapeutic agent and/or accidental ejection of themedical device.

Referring to FIG. 2, another example of a medical device deliveryapparatus 2 is illustrated. In this example, a balloon catheter 34 isslidably positioned within the lumen of a delivery catheter 36. A stent38 is positioned over the compressed balloon 40 at the distal end of theballoon catheter 34. A capsule 42 is positioned within the catheterlumen proximal of the balloon 40 on the balloon catheter 34. Anactivation element 44 is coupled to the shaft of the balloon catheter 34for releasing the therapeutic agent from the capsule 42. A separator 46is positioned on the shaft of the balloon catheter 36 proximal of thecapsule 42. The separator 46 keeps the released therapeutic agent in theproximal portion of the catheter. In one variation, the separatorincludes a stopper, coupled to the shaft of the balloon catheter, asshown in FIG. 2. In another variation the separator includes a seal. Inyet another variation, the separator include a one-way valve, whichpermits fluid flow in the distal direction but not the proximaldirection. The valve may allow the user to purge the air from the lumenof the catheter by injecting a liquid into the proximal end of thedelivery catheter. Once the catheter lumen is filled with the liquid,the user can release the therapeutic agent from the capsule. Thereleased therapeutic agent displaces the liquid at the distal portion ofthe catheter lumen proximal of the valve. The valve prevents orminimizes the therapeutic agent from dispersion in the proximaldirection. Although a separator 46 has been shown and described, theapparatus 2 can be provided without such a separator.

To release the therapeutic agent, the balloon catheter 34 is displacedin the proximal direction, which causes the activation element 44 toengage the capsule and release the therapeutic agent. The releasedtherapeutic agent flows distally to coat and/or load the stent 38. Inone variation, the stent includes a polymeric covering that absorbsand/or binds the therapeutic agent. After the stent has been implanted,the polymeric covering releases the therapeutic agent over time at theimplantation site.

In one variation, the reservoir containing the therapeutic agent is anintegral part of the delivery apparatus. In another variation, thereservoir containing the therapeutic agent includes an independent unitthat can be removed or detached from the delivery apparatus. FIG. 3illustrates a detachable capsule 48 that can be coupled onto the shaftof a pusher element or a balloon catheter. The capsule 48 includes alateral opening/slot 50 on the circumferential surface of the capsule48, such that the capsule can be clipped onto a shaft through thelateral opening.

In another embodiment, the medical device apparatus includes anelongated catheter and a deployment element slidably positioned withinthe lumen of the catheter. A stopper is positioned on the deploymentelement, such that axial displacement of the deployment element createsa negative pressure, which enables suction of a liquid or gel containinga therapeutic agent into the distal lumen of the catheter.

FIG. 4 illustrates this embodiment, in which a balloon catheter 52positioned within the lumen of a delivery catheter 54 includes a stopper56 coupled to the shaft of the balloon catheter 52. A medical device,e.g., a stent 58, is loaded on the balloon catheter 52. As the stopper56 is displaced distally and then withdrawn in the proximal direction,suction is created within the distal portion of the catheter lumen and aliquid or gel carrying a therapeutic agent can be drawn into the distalportion of the catheter lumen to coat and/or load the stent with thetherapeutic agent. The stopper 56 can be constructed to moveindependently of the medical device. In another approach, thetherapeutic agent can be injected into the lumen of the catheter throughthe distal end 60 of the catheter 54. In this approach, a separator(e.g., stopper) keeps at least a substantial portion of the injectedtherapeutic agent at the distal portion of the catheter lumen. Inanother variation (not shown), a syringe with a needle is utilized toinfuse the distal portion of the lumen with a therapeutic agent. Theneedle is inserted into the distal end of the catheter and extends pastthe loaded medical device, such that a gel or liquid therapeutic agentis injected proximal of the medical device. Once the therapeutic agentfills the area between the medical device 30 and the separator 62,further injection of the needle/syringe forces the therapeutic agent tomigrate distally to coat the medical device with the therapeutic agent.In yet another variation, another lumen can be provided to delivery asuitable bio-active material to an area proximate the medical device. Inthis variation, the lumen is couple to a syringe on the proximate end ofthe delivery mechanism.

FIG. 5 illustrates another example, in which an O-ring 64 is placedaround a pusher pad 66, such that the user can draw fluids into thedistal lumen of the catheter 68 by displacing the pusher element 70 in aproximal direction of the delivery apparatus 2. In this example, amedical device 72 (e.g., as a vascular filter, etc.) is positioned inthe distal lumen of the catheter for deployment. In one variation, asuitable guide-wire or mechanism can be used to prevent movement of themedical device 72 relative to the catheter 68.

FIG. 6 illustrates another variation, in which a polymeric disk 74 ispositioned over the shaft of a pusher rod 76 to serve as a separator.The polymeric disk 74 is configured with a plurality of slits 78, suchthat it can act as a unidirectional valve to permit fluids infusedthrough proximal end of the catheter to travel past the polymeric disk74 and into the distal portion of the catheter lumen 80, but essentiallyprevent its flow back proximally. The separator along with the wall ofthe catheter forms a chamber at the distal end of the catheter forhousing a medical device for deployment. Once the medical device isloaded in the distal end of the catheter, a suitable therapeutic agentcan be infused/injected into the distal end of the catheter to coatand/or load the catheter with the therapeutic agent. In one approach,saline is first injected into the proximal end of the catheter todisplace the air within the lumen of the catheter. A therapeutic agentis then injected through the distal opening to displace the salinewithin the distal portion of the catheter lumen. In another approach, aliquid therapeutic agent is injected directly into the proximal end ofthe catheter to fill both the proximal portion and the distal portion ofthe catheter lumen.

In another aspect, the delivery apparatus 2 includes a reservoir 4 atthe distal end thereof, through which a medical device 30 can bedelivered. FIG. 7 illustrates one example where two valves 82, 84 arepositioned within the lumen of a catheter 86 to form a chamber 88. Thevalves 82, 84 can be bi-directional valves. In a variation,uni-directional valves can also be implemented. The chamber 88 serves asa reservoir to hold a therapeutic agent. In one variation, each of thevalves 82, 84 includes a polymeric slit valve. In the particular exampleshown in FIG. 7, each of the valves 82, 84 includes a polymeric diskincluding a plurality of slits. The valves 82, 84 can be configuredsegmented slits such that that the valves can deform in one directionbut not in the opposite direction. Prior to the delivery of the medicaldevice 30, a therapeutic agent is injected into the chamber 88. In onevariation, the therapeutic agent is carried in a liquid substance. Inanother variation, the therapeutic agent is carried in a gel-likesubstance. To deploy the medical device, the user advances the pusherelement 90 distally and forces the medical device 30, through the valve84, into the chamber 88 filled with the therapeutic agent. The catheter86 is then inserted into the patient's body. Once the catheter 86 is inposition, the medical device 30 is pushed through the distal valve 82and ejected out of the catheter for deployment within the patient'sbody. In another approach, the delivery apparatus is inserted into thepatient's body while the medical device is still positioned proximal ofthe chamber 88. Once the catheter is positioned in place, the medicaldevice 30 is advanced distally through the chamber 88 and out the distalend 92 of the delivery apparatus 2. As the medical device 30 passesthrough the chamber 88, the medical device 30 is coated with thetherapeutic agent.

In another variation, the delivery apparatus includes an elongated bodyincluding a chamber at the distal portion of the elongated body. Thechamber is configured to hold a medical device for delivery into apatient's body. While the device is inside the chamber, the user caninfuse the chamber with a therapeutic agent to coat and/or to load themedical device with the therapeutic agent. In one approach, thetherapeutic agent is loaded into the chamber while the catheter is stilloutside the patient's body. In another approach, the therapeutic agentis loaded into the chamber after the delivery apparatus has beeninserted into a patient's body.

FIG. 8 illustrates another example where a delivery apparatus 2 includesan elongated catheter 94 with a chamber 96 positioned within the distalend of the elongated catheter 94. A balloon catheter 98 carrying amedical device, such as for example a stent 100, is slidably positionedin the lumen of the elongated catheter 94. The stent 100 along with theballoon 102 on the balloon catheter 98 is positioned in the distalchamber 96. The chamber 96 is formed with a valve 104 and a separator106 (e.g., seal, valve, etc.) positioned within the lumen of thecatheter 96. The medical device 100 can be placed in the catheter 94with the medical device positioned distal of the valve 106. In onevariation, the chamber 96 is loaded with a therapeutic agent byinserting a needle on a syringe through the distal valve 104 andinjecting a therapeutic agent into the chamber 96. In another variation,the shaft 108 of the balloon catheter includes two lumens. A first lumenis utilized to inflate and deflate the balloon 102, while a second lumenin conjunction with port 110 can be utilized to inject a therapeuticagent into the distal chamber 96 within the catheter 94. The therapeuticagent is injected into the second lumen at the proximal end of theballoon catheter. The therapeutic agent then travels down the length ofthe balloon catheter 98, and exits port 110, which is located close tothe balloon 102 at the proximal portion of the catheter shaft 98, andinto the chamber 96. Once the stent 100 is coated and/or loaded with thetherapeutic agent, the stent 100 can be deployed by advancing theballoon 102 on the balloon catheter 98 out of the catheter 94, anddilating balloon 102 to expand the stent 100.

In another example, the delivery apparatus 2 includes a stopper 112attached to the shaft of a balloon catheter 114 as shown in FIG. 9. Thestopper 112, along with a valve 116 positioned within the distal end ofthe catheter, forms a chamber 118 when the balloon catheter 114 isretracted within the lumen of the delivery catheter 120. In onevariation, the user can infuse the chamber with a therapeutic agent tocoat and/or load the medical device 30 (e.g., stent, vascular graft,etc.) positioned on the balloon catheter 114 through the distal end ofthe catheter. The infusion can be accomplished by a separate lumen andport 110, or by a neele through the distal end, or by filing thecatheter with therapeutic agent prior to insertion of the device 30. Inanother variation, the shaft of the balloon catheter includes a channelto allow the user to infuse the chamber with a therapeutic agent byinjecting the therapeutic agent through the distal end of the ballooncatheter. In yet another variation, the delivery catheter is configuredwith a second lumen, such that therapeutic agent can be injected intothe chamber through the proximal end of the delivery catheter.

In another aspect, the delivery apparatus 2 includes a medical devicedeploying mechanism 122. The medical device deploying mechanism isintegrated with a reservoir 4 for holding a therapeutic agent fordeployment into the lumen of the delivery apparatus. The therapeuticagent can be released into a chamber 124, which holds a medical device,to coat and/or load the medical device with the therapeutic agent. Inone variation the deploying mechanism 122 is slidably positioned withina lumen in the delivery apparatus 2.

FIG. 10 illustrates one example, where the delivery apparatus 2 includesan elongated catheter 126 and a pusher element 128 slidably disposedwithin the lumen of the elongated catheter 126. The distal portion ofthe pusher element 128 includes a chamber 130 for containing atherapeutic agent. The distal end of the chamber 130 includes an orifice132 for releasing the therapeutic agent into the lumen of the catheter126. In one variation, a valve 134 (e.g., a polymeric slit valve, etc.)is positioned over the orifice 132. A displacement mechanism 136 isplaced within the chamber 130 to allow the user to control the releaseof the therapeutic agent from the chamber 130. In the particular exampleshown in FIG. 10, a balloon/diaphragm 138 is positioned at the proximalend of the chamber 130. The shaft of the pusher element 128 includes alumen 140 in fluid communication with the balloon/diaphragm 138, suchthat the user can inject a fluid into the proximal end of the pusherelement to inflate the balloon and force the therapeutic agent out theorifice at the distal end of the chamber. The valve 134 can be a checkvalve with a suitable break pressure rating to prevent prematuredeployment of the therapeutic agent outside of the reservoir.

In yet another variation, the valve 134 can be eliminated with theexpandable member 138 inflated to occupy a substantial volume of thechamber. Deflation of member 138 can be used to generate suction offluid (gas or liquid or a combination thereof) through orifice 132.Subsequent expansion of the member 138 can be utilized to eject thesuctioned fluid.

FIG. 11A illustrates another example, where a capsule 142 is positionedwithin the chamber of the pusher element 144. A medical device 30 (e.g.,a vascular filter, stent, etc.) is disposed in the lumen at the distalend of the catheter 146. A stop 148 is coupled to the shaft 150 of thepusher element 144 to constrain the amount of the pusher element'sdisplacement in the axial direction. A locking clip 152 is placed overthe proximal shaft of the pusher element to prevent accidentaldeployment of the medical device 30. An activation mechanism is providedfor releasing the therapeutic agent contained in the capsule 142. Inthis particular design, the activation mechanism includes an elongatedwire 154 with a tapered distal end 156, as shown in FIG. 11B. Theelongated wire 154 can be inserted into the proximal end 158 of thepusher element 144 and down the lumen in the shaft 150. As the distalend 160 of the elongated wire 154 passes through the chamber 162, theelongated wire punctures the capsule 142 and releases the therapeuticagent contained therein. In one variation, the compartment within thecapsule is pressurizes such that once the integrity of the capsule hasbeen compromised, the therapeutic agent is forced out of the capsule dueto the pressure. In such a configuration, a suitable seal may beutilized to prevent flow of the therapeutic agent towards the proximalend. The seal can be, an elastomeric seal positioned between the wire154 and the lumen 140, or by a suitable tolerance fit between the lumen140 and wire 154 without the use of an elastomeric seal. The releasedtherapeutic agent exits the orifices 164 at the distal end of thechamber 162 coats and/or loads the medical device 30 with thetherapeutic agent. Once the medical device 30 has been coated and/orloaded with the therapeutic agent, the user can remove the locking clip152 and advance the pusher element 144 distally to eject the medicaldevice 30 out of the delivery apparatus 2. Slots 147, may be provided onthe inner lumen of the delivery catheter 146 for holding the medicaldevice 30. For example, slots 147 may be configured to interact with themedical device 30 to prevent the medical device 30 from rotating withthe lumen of the delivery catheter 146. In another variation, slots 147are configured to guide the movement of the medical device 30 as themedical device is being pushed out of the lumen of the delivery catheter146. In yet another variation, slots 147 are provided to preventappendages from the medical deice 30 from interfering with thedeployment of the medical device.

In another aspect, the delivery apparatus includes a lumen configuredfor delivering a therapeutic agent into a chamber that houses a medicaldevice for deployment inside a patient's body. A pressurized liquid orgel carrying the therapeutic agent may be transported through the drugdelivery lumen down the shaft of the delivery apparatus to coat and/orload the medical device housed in the distal portion of the deliveryapparatus.

In one example, as shown in FIG. 12, a separator 166 (e.g., valve, seal,etc.) is positioned within the lumen of a delivery catheter 168 to forma chamber 170 at the distal portion of the delivery catheter. Once themedical device 30 is loaded within the chamber 170, a therapeutic agentcan be injected into the chamber 170 to coat the medical device with atherapeutic agent. In one variation, the separator 166 includes aunidirectional valve. Saline is injected into the lumen of the catheter168 through the proximal side port 174 to purge air out of the lumen ofthe catheter. As the saline travels down the shaft of the deliveryapparatus, the separator 166 is pushed open and the chamber 170 at thedistal portion of the delivery apparatus 2 is filled with saline. Next,the user injects a therapeutic agent into the chamber 170 through theproximal end of the delivery apparatus to displace the saline therein.The side port 174 is utilized to provide a reservoir for the therapeuticagent. Continued filling of the reservoir can cause the chamber 170 tobe filled. As the therapeutic agent fills the chamber 170 the medicaldevice absorbs and/or is coated and/or is loaded with the therapeuticagent. Once the medical device has absorbed and/or is coated and/or isloaded with the therapeutic agent, the apparatus can then be insertedinto a patient's body for the deployment of the medical device. In theparticular example shown in FIG. 12, a balloon catheter 176 is utilizedto deploy a stent 178. However, other suitable delivery devices can alsobe utilized within the catheter 168 to deliver the medical device.

In another approach, the therapeutic agent is injected into the lumen ofthe delivery catheter through the port located at the proximal portionof the delivery apparatus to fill the lumen and coat and/or load themedical device with the therapeutic agent. In one design variation, theapparatus is configured without a separator 166. Therapeutic agent isinjected through the distal portion of the apparatus to completely fillthe lumen and coat and/or load the medical device with the therapeuticagent prior to inserting the delivery apparatus within the patient'sbody. Once the medical device is loaded with the therapeutic agent, thedelivery apparatus can be inserted into the patient's body to deploy themedical device. Before the delivery apparatus is inserted into thepatient's body, the user may infuse the lumen of the delivery apparatuswith saline to flush out the excess therapeutic agent within the lumen.

It is believed that the approach utilized for the embodimentsillustrated in, for example, FIG. 1-12, where the therapeutic agent isinfused prior to or during the implantation alleviates problemsassociated with the shelf-life of such agents being different from theshelf-life of the delivery apparatus or the implantable medical device.

In another variation, the delivery apparatus includes a dual lumendelivery catheter. The delivery catheter includes a first lumenproviding a conduit to allow the user to control the deployment of amedical device secured within the distal end of the delivery apparatus,and a second lumen providing a fluid conduit for transporting atherapeutic agent from the proximal end of the delivery apparatus to thedistal end of the apparatus in order to coat and/or load the medicaldevice with the therapeutic agent.

FIG. 13 illustrates the example where the delivery apparatus includes acoaxial dual lumen catheter 180 with a balloon catheter 182 slidablydisposed within the central lumen 184. The balloon 186 on the ballooncatheter 182 is shown in a deflated condition with a stent 188positioned over the deflated balloon. A therapeutic agent can beinjected down the outer lumen 190 to coat and/or load the stent 188 orstent-graft with the therapeutic agent. In one approach, the stent iscoated with the therapeutic agent prior to the insertion of the deliveryapparatus into the patient's body. In another approach, the stent 188 iscoated with the therapeutic agent while the delivery apparatus isinserted within the body of the patient. In yet another approach, atherapeutic agent is injected down the outer lumen 190 and thensuctioned up the central lumen 184 to induce a flow of the therapeuticagent over the medical device positioned in the distal end of thedelivery apparatus to facilitate coating and/or loading of the medicaldevice with the therapeutic agent. FIG. 14 illustrates another example,in which a medical device192 is positioned within a chamber at thedistal end of the delivery apparatus, and a pusher element 194 ispositioned within the central lumen of the delivery apparatus.

FIG. 15 illustrates another variation, in which an insert 196 ispositioned within the outer lumen 198 of the dual lumen deliveryapparatus 200. The displacement of the insert 196 allows the user togenerate a suction to induce the therapeutic agent to enter the distalchamber 202 and coat a medical device positioned therein. The insert 196may also be displaced proximally to create a reservoir at the distalportion of the outer lumen for containing a therapeutic agent. Later,the insert can be advanced distally to eject the therapeutic agent intothe chamber to coat the medical device. In another example, as shown inFIG. 16, the pusher element 204 is configured with a lumen 206, suchthat the user can inject a therapeutic agent down the shaft of thepusher element to infuse the proximal section of the delivery catheterwith a therapeutic agent. In one application, the lumen 206 of thepusher element is pre-filled with a therapeutic agent. When the user isready to coat the medical device 30 housed within the distal end of thedelivery catheter, the therapeutic agent is ejected out of the distalend of the pusher element 204.

FIG. 17 shows another example where a first catheter 208 is slidablydisposed within the lumen of a second catheter 210. The lumen of thefirst catheter 208 to can be utilized to infuse a therapeutic agent tocoat a medical device 30 positioned within the lumen of the secondcatheter 210. To deploy the medical device 30, the first catheter isadvanced distally to eject the medical device 30. In one variation, theinner catheter 212 further includes a cap 214 positioned at the distalend of the catheter 212, as shown in FIG. 18. An elongated wire 216 isslidably positioned within the lumen of the inner catheter 212. Astopper 218 is connected to the distal end of the elongated wire 216.The displacement of the elongated wire 216 in the proximal directionmoves the stopper 218 proximally and creates a chamber 220 within thelumen of the inner catheter 212. In one application, the stopper can bedisplaced to generate a suction. The suction draws a therapeutic agentinto the distal end of the outer catheter to coat the medical device 30positioned therein. In another application, the stopper can be displacedto create a reservoir that is pre-loaded with a therapeutic agent. Whenthe user is ready to coat the medical device with the therapeutic agent,the stopper is then advance distally to release the therapeutic agentinto the lumen of the outer catheter. Optionally, a valve is providedover the orifice of the cap positioned at the distal end of the innercatheter.

In another aspect, the delivery apparatus includes a delivery catheter224 and a pusher element 226 slidably disposed within the lumen of thedelivery catheter, as shown in FIG. 19A. The pusher element 226 includesan elongated wire 228 coupled to a pusher pad 230. The pusher pad 230includes flanges 232 that extend radially into the corresponding grooves234 on the inner lumen wall of the delivery catheter 224, as shown inFIG. 19B. The flanges 232 ensure that the pusher pad engages the medicaldevice, which is housed within the distal end of the delivery apparatus2, when the pusher pad 230 is advanced distally to eject the medicaldevice. This configuration may be particularly useful for engaging amedical device that has a large center opening (e.g., stent, etc.). Inone variation, the pusher pad 230 is further configured with channels toallow fluids to flow through the pusher pad, such that fluids infusedthrough the proximal end of the catheter can reach the distal end of thecatheter. In another variation, the pusher pad 230 includes a reservoirthat contains a therapeutic agent. In yet another variation, the pusherelement 226 includes a flexible rod connected to the pusher pad. Theflexible rod includes a lumen, such that a fluid injected into theproximal end of the flexible rod flows out at the distal end of thepusher pad.

FIG. 20 illustrates another variation of a delivery apparatus accordingto the present invention, comprising an elongated insert 240 slidablydisposed within the lumen of a catheter 242. A distal end 241 of theelongated insert 240 is inserted through a medical device 30 (e.g.,stent), which is positioned in the distal lumen of the catheter 242. Theelongated insert 240 includes a lumen 244 such that fluids can betransported down the shaft of the elongated insert 240. An orifice 246is positioned at the distal portion of the elongated insert 240 suchthat fluids injected into the lumen 244 of the elongated insert 240 canexit the elongated insert through the orifice 246. In one variation, theelongated insert is provided with a plurality of orifices 246, which aredistributed on the circumferential surface at the distal section of theelongated insert 240. The plurality of orifices 246 may be configuredsuch that fluids ejected out of theses orifices can distributed over thelength of the stent, which is positioned around the distal section ofthe insert. In one variation, the orifices 246 are distributed over thedistal section of the elongated insert in a spiral pattern. An optionalflange or disk 248 may be attached to the shaft of the elongated insert240, such that the advancement of the elongated insert 240 in the distaldirection causes the flange 248 to engage the medical device 30 andforce the medical device out of the distal end 250 of the deliverycatheter 242. In one variation, the flange 248 is configured withthrough holes 252 (FIG. 20), such that fluid injected into the proximalend of the delivery catheter lumen can travel past the flange and enterthe distal section of the catheter lumen. In another variation, theelongated insert is configured such that it can be rotated axially inrelation to the catheter 242. The axial rotation of the elongated insertcan be used to facilitate the distribution of the therapeutic agent overthe medical device.

In the above application, a therapeutic agent is injected into theproximal end of the elongated insert 240. The therapeutic agent travelsdown the lumen 244 in the shaft of the elongated insert 240 toward thedistal end 241 of the elongated insert. The therapeutic agent exits theorifices 246 on the distal section of the elongated insert 240 and coatsthe stent 30 positioned around the distal section of the elongatedinsert 240. Once the stent 30 is coated with the therapeutic agent, theelongated insert 240 can be advanced distally to deploy the stent 30. Inanother variation, the elongated insert is configured for coating thestent with a therapeutic agent only. Once the stent is coated with thetherapeutic agent, the elongated insert is removed, and a pusher elementis inserted into delivery catheter to deploy the stent.

FIG. 21A illustrates another variation of a delivery apparatus 2comprising a dual lumen catheter 260. A medical device 30 (e.g., stent,etc.) is slidably positioned in inner lumen 262 of the catheter 260 atthe distal section of the catheter. The wall between the inner 262 andthe outer 264 lumen includes a plurality of orifices 266 at the distalsection thereof to enable fluid communication between the inner lumen262 and the outer 264 lumen, as shown in FIG. 21B. A therapeutic agentcan be injected into the outer lumen at the proximal end of thecatheter. The therapeutic agent flows distally through the outer lumen264 and through the orifices 266 to enter into the inner lumen 262 andinto contact with the medical device 30. If the medical device 30includes, an absorption member, a porous member, or a sponge-likematerial, the therapeutic agent can be absorbed into the body of themedical device. Once the medical device is coated and/or loaded with thetherapeutic agent, it can then be deployed within the patient's body.

It should be noted that the various embodiments described herein can beutilized with a reservoir located in the catheter or a reservoirexternal to the catheter.

FIG. 22 shows another variation where the delivery apparatus 2 furtherincludes a pusher element 268 for deploying the medical device 30 fromthe inner lumen 270 of the catheter 272. In this particular example, amedical device (e.g., a vascular filter 294) is loaded in the innerlumen 270 of the dual lumen catheter. In this embodiment, the distal endof the catheter can be configured with one or more slots 276 to separatethe appendages 278, if any, on the medical device 30, such as a vesselfilter having a plurality of legs, and prevent the appendages fromentangling with each other.

FIG. 23 illustrates another variation where the delivery apparatus 2includes a balloon catheter 280 carrying a stent 282 slidably disposedwithin a dual lumen catheter 284. A first port 286, located on theproximal section of the catheter, is configured for accessing the innerlumen 288, while a second port 290, also located on the proximal sectionof the catheter, is configured for accessing the outer lumen 292 of thecatheter. A therapeutic agent can be injected into either the outerlumen 292 or the inner lumen 288 to coat and/or load the stent 282positioned over the balloon on the balloon catheter 280. In oneapproach, the therapeutic agent is injected through one lumen whilebeing extracted through a section in the second lumen. As a result, aflow of therapeutic agent is generated over the stent for coating thesurface of the stent with the therapeutic agent. Optionally, a cap 294may be provided to cover the distal end of the catheter 284 when thestent 282 is being coated within the inner lumen of the catheter 284. Inone variation, the cap includes a polymeric layer, which provides a sealaround the tip of the catheter, and which is configured for placementover the tip of the catheter. In one example, two O-rings 296, 298 areplaced within the inner lumen of the cap 294 to provide the seal.Additionally, the cap 294 may also be utilized with other embodimentsdescribed herein.

FIG. 24 illustrates yet another variation of a delivery apparatus 2comprising a pusher element 300 slidably disposed in the inner lumen ofa dual lumen catheter 302. In this variation, the pusher element 300includes a lumen 304 to provide fluid communication through the lengthof the pusher element.

In another aspect of the invention, a medical device is coated orinfused with a therapeutic agent under pressure while positioned in adelivery apparatus. The delivery apparatus may be provided to the enduser (e.g., surgeon performing the implant procedure, etc.) with themedical device pre-loaded in the delivery apparatus. In anothervariation, the end user has to load the medical device in the deliveryapparatus prior to implantation. With the medical device loaded in thedelivery apparatus, a therapeutic agent, which is pressured in acontainer, is infused or injected into the chamber of the deliveryapparatus housing the medical device. The therapeutic agent can beinjected into the delivery apparatus in various forms including, but notlimited to, mist, spray, foam, liquid stream, or gel stream. Variousdelivery mechanisms (e.g., spray pump, aerosol can, pressure pump, etc.)can be utilized to infuse the therapeutic agent into the deliveryapparatus to coat and/or load the medical device therein.

Referring to FIG. 25, an adaptor 310 is provided with interfaces tocouple a therapeutic agent injection mechanism 312 (e.g., a pressuregenerating source configured to eject the therapeutic agent) to thedistal end of a delivery apparatus. In one variation, the deliveryapparatus 2 includes a catheter 314 with a deployment mechanism 316positioned within the lumen of the catheter. A medical device 30 ispositioned in a chamber within the distal section of the catheter lumen.The adaptor 310 is connected to the nozzle 318 of an aerosol can 320,which carries a therapeutic agent. The distal end of the adaptor 310 hasan interface that receives the nozzle of the aerosol can, and theproximal end of the adaptor has an interface 322 that receives thedistal end 324 of the catheter 314 and forms a seal around the cathetertip. The user inserts the distal end 324 of the catheter 314 into theadaptor 310. The lever on the aerosol can is then depressed to infusethe therapeutic agent into the lumen of the catheter to coat and/or loadthe implantable medical device with the therapeutic agent.

In another aspect of the invention, a reservoir containing a therapeuticagent is configured for attachment onto the distal end of the deliveryapparatus (e.g., delivery catheter, etc.). Once the reservoir isconnected to the distal end of the catheter, the user can release thetherapeutic agent into the lumen of the delivery apparatus to coatand/or load the medical device located in the delivery apparatus.Referring to FIG. 26, a reservoir 4, including a cap 330 containing acapsule 332 filled with a therapeutic agent is inserted over the distalend of the delivery apparatus 2. The user applies a pressure over thecap 330 to break the capsule 332 and release the therapeutic agent. Thereleased therapeutic agent flows into the lumen 334 of the catheter 336and coats the medical device 30 positioned therein. In one variation,the compartment within the capsule is pressurized.

In another variation, the delivery apparatus is provided to the userwith a reservoir of a therapeutic agent connected to the distal end ofthe catheter. A medical device is pre-loaded in the delivery apparatus.When the user is ready to insert the medical device into the patient,the user releases the therapeutic agent from the reservoir to coatand/or load the medical device. In one variation, the reservoir ispressurized to facilitate the ejection of the therapeutic agent from thereservoir. Once the coating/loading process is completed, the user thendisconnects the reservoir from the distal end of the delivery apparatus.With the reservoir removed, the user can insert the delivery apparatusinto the patient and deploy the medical device.

A container can be attached to the distal end of a delivery apparatus. Avalve can be provided on the container to control the outflow of atherapeutic agent retained within the reservoir. To coat the medicaldevice, the user releases the valve and allows the therapeutic agent toflow into the lumen of the delivery apparatus. Once the medical deviceis coated with the therapeutic agent, the container is detached from thedistal end of the delivery apparatus. In another example, a deliveryapparatus includes a capsule 342 containing a therapeutic agentconnected to the distal end 344 of a delivery catheter 346, as shown inFIG. 27. A balloon catheter 348 carrying a compressed stent 350 isslidably disposed within the lumen of the delivery catheter 346. Thecompartment within the capsule 342 is pressurized, such that once thevalve or barrier 352 sealing the capsules opening is compromised, thetherapeutic agent will be forced out of the capsule 342 due to thepressure. To coat the stent 350 on the balloon catheter 348, the userpresses down on the neck 354 of the capsule to break the barrier 352sealing the proximal opening of the capsule. Once the barrier 352 hasbeen cracked, the therapeutic agent flows out of the capsule 342 andinto the lumen 356 of the delivery catheter 346. Once the stent 350 iscoated with the therapeutic agent, the user bends the capsule 342relative to the delivery catheter 346, and breaks the capsule 342 offthe delivery catheter 346. With the capsule removed, the distal end ofthe delivery catheter along with the stent and the balloon catheter canbe inserted into an introducer sheath 346 and into a patient's body.Once the balloon catheter is positioned in the desired location withinthe patient, the delivery catheter is retracted to expose the stent. Theballoon on the balloon catheter is then inflated to deploy the stent.

In another variation, the delivery apparatus includes a deliverycatheter including a plurality of orifices positioned on thecircumferential surface at a distal section of the delivery catheter.The user can infuse or introduce a therapeutic agent through theseorifices to coat and/or load a medical device located in the lumen ofthe delivery catheter. For example, the delivery catheter along with amedical device, which is secured within the lumen of the catheter, maybe dipped into a liquid therapeutic agent or placed into a pressurizedchamber filled with a therapeutic agent. The therapeutic agent isdiffused through the orifices in the delivery catheter to coat and/orload the medical device.

FIG. 28 illustrates one example, where a delivery catheter 360 includinga plurality of circumferential orifices 362 is inserted into theproximal end of an adaptor 364. A balloon catheter 366 carrying amedical device is disposed within the lumen of the delivery catheter360. The medical device (e.g., stent 368) is aligned within the distalportion of the catheter, such that the orifices surround the medicaldevice. A syringe 370 filled with a therapeutic agent is attached to thedistal end of the adaptor 364. The user injects the therapeutic agentinto the chamber 372 within the adaptor. As the chamber 372 is filledwith the therapeutic agent, the therapeutic agent is forced into thelumen of the catheter 360 through the distal opening 374 and thesurrounding orifices 362. Once the stent 368 is coated with thetherapeutic agent, the user can remove the syringe along with theadaptor.

FIG. 29 illustrates another variation of an adaptor 364 design. In thisdesign, the adaptor includes an outer lumen and a central lumen. Theouter lumen 376 of the adaptor 364 directs therapeutic agents into thelumen 378 of the catheter 360 through the circumferential orifices 362on the distal section of the catheter. Excess therapeutic agent isallowed to flow out of the distal opening of the catheter and into thecentral lumen 380 of the adaptor 364. An opening 382 on the adaptor isprovided to allow the excess materials to exit the adaptor 364.

In another aspect, a sponge-like or porous material is positioned closeto the distal opening of a delivery apparatus. The sponge-like materialcan serve as a reservoir to retain a therapeutic agent. The therapeuticagent is pre-loaded or infused into the sponge-like material prior tothe deployment of the medical device. As the medical device is propelledout of the distal opening of the delivery apparatus, the medical deviceglides over the sponge-like material, and the therapeutic agent isprovided onto the surface of the medical device. The delivery of thetherapeutic agent can be by wicking, or by squeezing of the porousmaterial to force the agent on to the medical device.

In one example, as shown in FIG. 30, the delivery apparatus 2 includes adelivery catheter 390 including a polymeric layer 392 with highabsorbency attached to the inner wall of the catheter 390 at the distalportion of the catheter lumen. A balloon catheter 394 carrying a stent396 is slidably disposed within the lumen 398 of the delivery catheter390. The user first infuses the polymeric layer 392 with a therapeuticagent. The delivery catheter 390 along with the stent 396 and theballoon catheter 394 are then inserted into an introducer sheathpositioned within the patient's body. Once the balloon catheter 394 ispositioned in the desired location, the user can either advance theballoon catheter 394 relative to the delivery catheter 390, or retractthe delivery catheter 390 relative to the balloon catheter 394, todeploy the stent. As the stent 396 passes over the polymeric layer 392,the therapeutic agent is delivered onto the surface of the stent 396.

In another example, the delivery apparatus includes a delivery catheter390 with a sponge-like layer 400 positioned around the distal lumensection. A stent 396 is slidably positioned with the lumen of thecatheter 390, as shown in FIG. 31. A pusher element 402 is position withthe lumen 398 proximal of the stent 396. The user first infuses thesponge-like layer 400 with a therapeutic agent. Once the sponge-likelayer 400 is infused with the therapeutic agent, the user may advancethe stent 396 distally and position the stent within the sponge-likelayer 400. Next, the delivery catheter 390 is inserted into thepatient's body, and the stent 396 is deployed through the distal opening404 of the delivery catheter 390. In another variation, the sponge-likelayer in the delivery apparatus is pre-loaded with a therapeutic agentbefore the delivery apparatus is provided to the user.

In another aspect, the medical device configured for deployment with thedeployment apparatus can include a coating to facilitate the retentionof the therapeutic agent on the medical device. For example, a coatingwith affinity for binding a therapeutic agent may be implemented on amedical device. In one variation, a biocompatible polymer with affinityto one or more therapeutic agents can be coated on the surface of themedical device. In another example, a gelatin, a hydrogel, or otherhydrophilic or hydrophobic polymers may be integrated in the medicaldevice to absorb and/or retain the therapeutic agent. The polymericlayer can be configured to allow slow release of the therapeutic agentover time after the device has been deployed within the patient's body.Polymers which may be suitable for incorporating on a medical device asdrug carrier include, but not limited to, Poly(urethanes),Poly(siloxanes), Poly(methyl methacrylate), Poly(vinyl alcohol),Poly(ethylene), Poly(vinyl pyrrolidone), Poly(2-hydroxy ethylmethacrylate), Poly(N-vinyl pyrrolidone), Poly(methyl methacrylate),Poly(vinyl alcohol), Poly(acrylic acid), Polyacrylamide,Poly(ethylene-co-vinyl acetate), Poly(ethylene glycol), Poly(methacrylicacid), Polylactides (PLA), Polyglycolides (PGA),Poly(lactide-co-glycolides) (PLGA), Polyanhydrides, Polyorthoesters.Other absorptive materials or scaffold with reservoir for retainingliquid that are well known to one skilled in the art may also beutilized on the medical device for retaining therapeutic agent.

In yet another aspect, methods for loading (e.g., infusing, absorbing,coating, etc.) a medical device with a therapeutic agent while themedical device is positioned in the lumen of the catheter is disclosedherein. In one example, the method includes providing a medical device,a therapeutic agent, and a delivery apparatus to a medical practitioner.The medical device, the therapeutic agent, and the delivery apparatuscan be provided to the medical practitioner in an integrated packagingor as separate items. In one variation, the delivery apparatus and themedical device are provided in a single sterile package, and thetherapeutic agent is provided in a separate container. The medicaldevice can be pre-loaded in the delivery apparatus before packaging.Alternatively, the medical device can be provided as separated items inthe packaging. The medical device and delivery apparatus integratedpackage can also be provided to the medical practitioner as a single usedeposable system. The integrated packaging may minimize confusion inmatching the appropriate delivery apparatus with the medical device.Once the medical device is implanted, the medical practitioner maydispose of the delivery apparatus. By packaging the therapeutic agentseparately, the medical practitioner can selected the appropriatemedication base on specific patient need and the requirements of thespecific implant procedure. In some application, the therapeutic agentmay need to be refrigerated or store in an environmental controlchamber. Storing the therapeutic agent separately from the medicaldevice and the delivery apparatus may maximize storage efficiency.

In another variation, the therapeutic agent is packaged with thedelivery apparatus, and the medical device is provided as a separateunit. This approach may allow the manufacturer to match up a therapeuticagent with the appropriate delivery apparatus. The medical practitionercan then select the appropriate medical device for deployment with thedelivery apparatus. For example, the medical practitioner may select themedical device from a group of devices based on type, functionalcapability, size, material property, etc. In yet another variation, thetherapeutic agent is provided in the same packaging as the medicaldevice, and the delivery apparatus is provided separately. In someapplication, a particular therapeutic agent may be especially suitablefor use with a specific medical device. Thus, it would be convenient forthe manufacture to package the therapeutic agent with medical device.Furthermore, it may also be useful to package an interface (e.g., auniversal syringe adaptor, aerosol can adaptor, etc.) and/or atherapeutic agent loading mechanism (e.g., a syringe, etc.) with thedelivery apparatus. In certain application, the manufacture can alsoprovide a medical device loading instrument along with the deliverydevice to assist the medical practitioner to insert the medical deviceinto the delivery apparatus.

As discussed above, the medical device can be provided to the medicalpractitioner preloaded in the delivery apparatus or it can be providedto the medical practitioner as a two separate items, requiring themedical practitioner or his assistant to load the medical device intothe delivery apparatus prior to deployment. The therapeutic agent may beprovided to the medical practitioner as an integrated package having thetherapeutic agent along with the delivery apparatus and/or the medicaldevice. The therapeutic agent, the medical device, and the deliveryapparatus, may also be provided to the medical practitioner asindividual units.

With the device loaded in the delivery apparatus, the therapeutic agentis infused into the delivery apparatus to load the medical device withthe therapeutic agent. For example, a syringe may be utilized to injectthe therapeutic agent into the delivery apparatus either from theproximal end or the distal end of the delivery apparatus, depending onthe design of the specific delivery apparatus. A syringe adaptor may beprovided for coupling the syringe with the delivery apparatus. In onevariation, the therapeutic agent is preloaded into a syringe. The usercan remove a cap on the syringe and insert the tip of the syringe intothe distal opening of the delivery apparatus. The therapeutic agent isthen injected into the lumen of the delivery apparatus to load themedical device with the therapeutic agent. In another variation, thetherapeutic agent is provided within a container. A syringe with theneedle can be used to extract the therapeutic agent out of its containerand into the syringe. The needle on the syringe can then be insertedinto the distal end of the delivery apparatus to inject the therapeuticagent. Alternatively, the needle can be removed, and the tip of thesyringe inserted into the distal end of the delivery apparatus to infusethe therapeutic agent. In another variation, an adapter is provided tocouple the syringe to the distal tip of the delivery apparatus to assistwith the injection of the therapeutic agent into the delivery apparatus.As one skilled in the art having the benefit of this disclosure wouldappreciate, the syringe could also be utilized to inject therapeuticagent into the proximal end of the delivery apparatus.

In another example, an aerosol can carrying the therapeutic agent iscouple to the delivery apparatus (either directly or through an adaptor)to infuse the inner chamber of the delivery apparatus, which holds themedical device. In one variation, the therapeutic agent is loaded ontothe medical device, which is positioned in the delivery apparatus,before the delivery apparatus is inserted into the patient's body. Inanother variation, the therapeutic agent is loaded onto the medicaldevice after the delivery apparatus, along with the medical device, hasalready been inserted into the patient's body.

In yet another example, the therapeutic agent is provided to the medicalpractitioner in a pump dispenser (e.g., spray pump, microsprayer, lotionpump, trigger sprayer pump, pressure sprayer, mist sprayer, etc.). Withthe medical device positioned in the deployment apparatus, the medicalpractitioner dispenses the therapeutic agent out of the pump dispenserand into the delivery apparatus to load the medical device with thetherapeutic agent. An adaptor can be used to facilitate the transfer ofthe therapeutic agent from the pump dispenser into the deliveryapparatus. In addition, the method for loading the medical devicepositioned in the delivery apparatus can also include the step ofpressurizing the pump dispenser or other container containing thetherapeutic agent, prior to injecting or spraying the therapeutic agentinto the delivery apparatus to load the medical device with thetherapeutic agent. The pressurizing step may include activating a pumpto increase the pressure inside of a canister containing the therapeuticagent. In another variation, the pressurizing step comprises shaking acanister (e.g., an aerosol canister, etc.) containing the therapeuticagent to increase the pressure in the canister.

One skilled in the art having the benefit of this disclosure wouldappreciate that some variations of the delivery apparatus disclosedherein may be applicable for simultaneous delivery of a therapeuticagent and a medical device into a pre-selected site within a patient'sbody. The medical device chamber of the delivery apparatus may bepre-loaded with a therapeutic agent, such that the therapeutic agent andthe medical device can be introduced into the pre-selected site withinthe patient's body simultaneously. It should also be appreciated thatduring the deployment of the medical device, a therapeutic agent mayalso be injected through a drug lumen in the delivery apparatus toinfuse the deployment site with a therapeutic agent.

As discussed above, the medical device disclosed herein may beconfigured to serve as a carrier to deliver a therapeutic agent onto atarget site within a patient's body. For example, a method utilizing amedical device as a gene therapy delivery platform is described below.The delivery apparatus is configured to deliver the medical device,which carries stem cells or a gene therapy agent, to a pre-selectedlocation within the patient's body. In one variation, the medical deviceincludes a stent covered with a polymeric layer configured to absorbproteins, nucleic acid chains and/or other large molecules is loaded inthe delivery apparatus. In one variation, while the stent is loaded inthe delivery apparatus, Vascular Endothelial Growth Factor-2 (VEGF-2) inthe form of naked DNA plasmid, a nonviral vector, is loaded into thepolymeric layer on the stent. With the VEGF-2 loaded on the stent, thedelivery apparatus is inserted into the patient's body to deploy thestent at the pre-selected site. In another approach, the gene therapyagent is loaded in a reservoir in the distal portion of the deliveryapparatus. Immediately prior to or during the deployment of the stent,the gene therapy agent is then released into the lumen of the deliveryapparatus.

One skilled in the art having the benefit of this disclosure would alsoappreciate that the delivery apparatus disclosed herein is not limitedfor loading and/or coating a medical device with a therapeutic agent fordeployment inside a patient's body. Various other chemicals,biochemical, and biologics may also be coated and/or loaded onto amedical device for delivery into a patient's body.

While the invention has been described in terms of particular variationsand illustrative figures, those skilled in the art will recognize thatthe invention is not limited to the variations or figures described. Inaddition, where methods and steps described above indicate certainevents occurring in certain order, those skilled in the art willrecognize that the ordering of certain steps may be modified and thatsuch modifications are in accordance with the variations of theinvention. Additionally, certain of the steps may be performedconcurrently in a parallel process when possible, as well as performedsequentially as described above. Therefore, to the extent there arevariations of the invention, which are within the spirit of thedisclosure or equivalent to the inventions found in the claims, it isthe intent that this patent will cover those variations as well.Finally, all publications and patent applications cited in thisspecification are herein incorporated by reference in their entirety asif each individual publication or patent application were specificallyand individually put forth herein.

1. A delivery apparatus comprising: a catheter including a first lumen;a medical device positioned in a distal portion of the first lumen; adeployment mechanism slidably disposed in the first lumen; and aseparator disposed in the first lumen, separating the distal portion ofthe first lumen from a proximal portion of the first lumen.
 2. Thedelivery apparatus according to claim 1, wherein the separator preventsa therapeutic agent in the distal portion of the first lumen frommovement into the proximal portion of the first lumen.
 3. The deliveryapparatus according to claim 1, wherein the separator is coupled to thedeployment mechanism.
 4. The delivery apparatus according to claim 1,wherein the separator comprises a unidirectional valve.
 5. The deliveryapparatus according to claim 1, wherein the deployment mechanismincludes an infusion lumen and a plurality of orifices disposed along adistal portion thereof.
 6. The delivery apparatus according to claim 1,further comprising a second lumen positioned coaxially with respect tothe first lumen and in fluid communication therewith.
 7. The deliveryapparatus according to claim 6, wherein the second lumen is coaxiallypositioned around the first lumen, a wall separating the first andsecond lumens including a plurality of orifices along a distal portionthereof.
 8. A drug loading system, comprising: a medical device deliveryapparatus including a medical device disposed in a distal portionthereof; an injection mechanism containing a therapeutic agent; and anadaptor coupling the injection mechanism to a distal end of the deliveryapparatus and directing the therapeutic agent from the injectionmechanism into the distal portion of the delivery apparatus to coatand/or load the medical device.
 9. The drug loading system according toclaim 8, wherein the therapeutic agent comprises a material selectedfrom a group consisting of a stem cell, a gene therapy agent, a protein,a nucleic acid chain, a growth factor, and combinations thereof.
 10. Thedrug loading system according to claim 8, wherein the adaptor comprisesa first lumen for directing the therapeutic agent into the deliveryapparatus, and a second lumen for directing an excess portion of thetherapeutic agent out of the lumen of the delivery apparatus.
 11. Thedrug loading system according to claim 8, wherein the adaptor furthercomprises an interface for receiving a distal portion of the deliveryapparatus.
 12. A method for implanting a medical device, comprising:disposing a portion of the medical device in a delivery apparatus; andreleasing a therapeutic agent from a reservoir to coat and/or load themedical device.
 13. The method according to claim 12, further comprisingthe steps of inserting the delivery apparatus into a patient's body, anddeploying the medical device into the patient's body.
 14. The methodaccording to claim 12, wherein the reservoir is pressurized prior to thereleasing step.
 15. The method according to claim 12, wherein thereservoir is positioned in the delivery apparatus.
 16. The methodaccording to claim 12, wherein the reservoir is separate from thedelivery apparatus, the method further comprising the step of couplingthe reservoir to the delivery apparatus before releasing the therapeuticagent from the reservoir to load the medical device.
 17. The methodaccording to claim 16, further comprising the steps of providing themedical delivery apparatus to a medical practitioner, and providing acontainer comprising the reservoir to said medical practitioner.
 18. Amethod for delivering a drug to a patient, comprising: contacting amedical device with a therapeutic agent while the medical device isdisposed in a distal portion of a delivery apparatus; inserting thedelivery apparatus in a patient's body; and deploying the medical devicein the patient's body.
 19. The method according to claim 18, wherein thecontacting step comprises injecting the therapeutic agent into aproximal end of the delivery apparatus and allowing the therapeuticagent to travel to the distal portion to coat the medical device priorto inserting the delivery apparatus in the patient's body.
 20. Themethod according to claim 19, wherein the contacting step comprisesinjecting the therapeutic agent into the distal portion of the deliveryapparatus to coat the medical device prior to inserting the deliveryapparatus into the patient's body.